Paclitaxel and GM-CSF in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Giving paclitaxel together with GM-CSF may be effective in treating melanoma.
PURPOSE: This phase II trial is studying how well giving paclitaxel together with GM-CSF works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Clinical Efficacy of Leukine® Administered in Conjunction With Paclitaxel in Patients With Advanced Melanoma|
- Clinical response by CT scans every 6 weeks [ Designated as safety issue: No ]
- Duration of response by CT scans every 6 weeks [ Designated as safety issue: No ]
- Time to progression by CT scans every 6 weeks [ Designated as safety issue: No ]
- Survival [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
- Assess the activity of paclitaxel and sargramostim (GM-CSF), in terms of objective clinical response rate (complete response [CR] and partial response [PR]), in patients with advanced unresectable melanoma.
- Evaluate the duration of response, time to progression, and overall survival of patients treated with this regimen.
- Determine serum cytokine levels (GM-CSF, IFN-γ, aldesleukin, recombinant interleukin-4, and IL-10) in these patients.
OUTLINE: This is an open-label study.
Patients receive paclitaxel IV over 3 hours on day 1 and sargramostim (GM-CSF) subcutaneously on days 4-17. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses of therapy beyond CR for up to 12 courses.
After study treatment, patients are followed every 3-6 months for at least 3 years.
PROJECTED ACCRUAL: A total of 42 patients will accrued for this study.
|United States, Virginia|
|University of Virginia Cancer Center|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||William W. Grosh, MD||University of Virginia|